Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections

Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07725848

Acronym

CP-CUTI

Enrollment

200

Registered

2026-07-24

Start date

2026-10-15

Completion date

2029-10-15

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistance, Complicated Urinary Tract Infections

Keywords

Complicated Urinary Tract Infections, Cefepime/Enmetazobactam (FEP/META), Bacteremia, Antibiotic Resistance, Beta-lactamase Producers, OXA-48-type Carbapenemase Producers

Brief summary

This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases. The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.

Detailed description

The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers). This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy. Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT * Adult population (age ≥ 18 years) * Signed informed consent form

Exclusion criteria

* Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs * Patients with negative blood cultures * Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms) * Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture * Patients treated with inappropriate therapy for more than 48 hours * Patients discharged early without follow-up blood cultures * History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the timing of microbiological eradication	Within two weeks from the antibiotic therapy initiation	To evaluate the timing of microbiological eradication in patients who received cefepime/enmetazobactam (FEP/META) compared to best available therapy (BAT) for targeted treatment of bacteremic complicated urinary tract infections (cUTIs) due to ESBL/OXA48 producers Gram-negatives

Secondary

Measure	Time frame	Description
To investigate clinical cure	At day 3-7 after positive blood culture between two groups	To investigate clinical cure (defined as complete resolution of baseline signs and symptoms present at screening) at day 3-7 after positive blood culture between two groups

Countries

Italy

Contacts

CONTACTCecilia Maria Bonazzetti, MD

cecilia.bonazzetti@unibo.it+390512143595

CONTACTMaddalena Giannella, MD, PhD

maddalena.giannella@unibo.it+390512143199

PRINCIPAL_INVESTIGATORCecilia Maria Bonazzetti, MD

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Outcome results